Reprocessing of reusable medical devices

To ensure appropriate risk management of the reprocessing of reusable medical devices (RMD), all staff involved must adhere to relevant local health network, state, national and international standards and guidelines, and the National Safety and Quality Health Service Standards. AS5369 Reprocessing of reusable medical devices and other devices in health and non-health related facilities describes requirements across all healthcare settings as well as non-health settings in which devices with infection control risks are reprocessed between clients. All sterilising facilities should have access to this document.

Instructions for SA Health staff to access this standard electronically from the SA Health Library Service can be found on the Library Service’s Australian Standards page.

Prior to the adoption of AS5369 in December 2023, two separate standards applied;

  • AS/NZS4187, for hospital and acute settings
  • AS/NZS4815, for office-based settings such as general practice, dental and medical specialists’ rooms

Please note that guidelines, audit tools and recommendations published by national and international organisations may be under revision as AS5369 is implemented. Resources to assist facilities transitioning from their previous standards are available from the Australian Commission on Safety and Quality in Health Care (ACSQHC).

Single-use and single-patient use devices

Items marked "single-use only" (PDF 81KB) or with this symbol must not be reprocessed.The number two in a circle with a diagonal line running through it
Items labelled "single-patient use", can be re-used on the same patient only, after reprocessing according to the manufacturer’s instructions.

Currently the regulatory requirements for the reprocessing of medical devices labelled as "single use" are covered by:

The importance of cleaning RMDs

Cleaning is the essential first step for any form of reprocessing:

  • initial cleaning of reusable medical devices should commence as soon as practicable after use
  • if an item cannot be thoroughly cleaned, it cannot be adequately reprocessed
  • failure to achieve adequate cleaning may result in ineffective disinfection or sterilisation of instruments or equipment.

Level of reprocessing RMDs

The item and its intended use determine the level of reprocessing required. The manufacturer’s instructions, health service policy, applicable guidelines and standards should all be taken into consideration when determining the most appropriate process. The "Spaulding classification" is often used to assess reprocessing requirements1 and is summarised as follows:

Critical risk

Application: Entry or penetration into sterile tissue, body cavity or bloodstream
Process: Sterilisation

Semi-critical risk

Application: Contact with intact mucous membranes or non-intact skin
Process: Sterilisation where possible. If sterilisation is not possible then high-level thermal or chemical disinfection is required

Non-critical risk

Application: Contact with intact skin only
Process: Clean as necessary with detergent and water (low or intermediate level disinfection after cleaning as required)

High-Level disinfection of RMDs

Semi-critical items such as endoscopes, laryngoscope blades and ultrasound probes/transducers that are used in body cavities or during surgery should ideally be sterilised, but many of these devices are incompatible with both steam and low temperature sterilisation, and therefore require high-level disinfection as the next most comprehensive process to render them safe to use on another patient. There are several automated high-level disinfection systems, including automated flexible endoscope reprocessors (AFERs), and specific standalone equipment for high-level disinfection of ultrasound probes.

Examples of effective high-level disinfectants include:

  • Ultraviolet C germicidal irradiation (UVGI)
  • ortho-phthalaldehyde solution at 0.55%
  • peracetic acid solution at 0.2%
  • hydrogen peroxide at 7.5-35% (as liquid or vapour preparations, respectively)

There are disadvantages with the use of any chemical disinfectant, such as occupational exposure and material compatibility. Chemical high level disinfectants must be monitored at each use for ongoing efficacy, and expiry dates must be strictly followed. For a summary of these issues see the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 (Table 5).

Ortho-phthalaldehyde (OPA) has largely replaced the use of glutaraldehyde in most healthcare facilities due to its superior microbicidal properties, shorter immersion time and safer risk profile. 

For detailed information on training and reprocessing of endoscopic devices, see the Gastroenterological Society of Australia Infection Control in Endoscopy Guidelines.

Auditing process

Compliance with AS5369:2023 can be assessed by using an audit tool issued by the Australian Commission on Safety and Quality in Health Care (ACSQHC).

All healthcare providers who reprocess reusable medical devices are responsible for meeting appropriate national standards of safety and quality in infection control. To support compliance with accreditation requirements the Australian Commission on Safety and Quality in Health Care provide standards and audit tools for health facilities.

This includes office-based and smaller medical practices where the comprehensive SALHN tool may not be suitable.

  • The Australian Dental Association (ADA) provides guidelines for infection control for dental facilities.
  • The Podiatry Board of Australia provides an audit tool for checking compliance with the Board’s infection control guidelines.
  • The RACGP publishes standards in infection control to guide General Practitioners and office-based practices. Audit tools may be available from the practice’s accreditation provider.
  • The Australian Commission on Safety and Quality in Health Care provide standards and audit tools for health facilities.

Ultrasound transducers

Ultrasound transducers are used in a variety of healthcare settings, and their Spaulding Classification may vary according to the internal or external tissues contacted during each use. Advice on the method of reprocessing required in each scenario including the use of sterile probe covers or sheaths, has been developed bu the Australian Society for Ultrasound in Medicine (ASUM) and the Australasian College for Infection Prevention and Control (ACIPC). The ACSQHC has produced a fact sheet to support the reprocessing of ultrasound transducers used for percutaneous insertion. Resources are as follows:

Training

Staff who perform reprocessing of reusable medical devices must be competent in all tasks. There are specific qualifications in Sterilisation Services and reprocessing available from independent institutions, for example:

  • Certificate III in Sterilisation Services (delivered by ANMEC and TIME)
  • Certificate IV in Sterilisation Services (delivered by ANMEC)
  • Reprocessing of endoscopes online learning package (GENCA).

Governance

There are various sources of information regarding governance requirements for the reprocessing of RMDs including The Australian Commission on Safety and Quality in Healthcare (ACSQHC) National Safety and Quality Health Service (NSQHS) Standard: Preventing and Controlling Infections Standard and SA Health Infection Prevention and Control and Healthcare Associated Infection (HAI) Surveillance and Reporting Policy.

Special Interest Group

The SA Health Reprocessing of Reusable Medical Devices Reference Group is a special interest group with meetings facilitated by SA Health DHW Infection Control Service, contact the Sterilising and Reprocessing Medical Device Reprocessing State Coordinator at HealthICS@sa.gov.au.

For information regarding the purpose and membership of this group, refer to the terms of reference.

Further information

For further information on reprocessing of medical devices, contact SA Health's Infection Control Service.

1 Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) | NHMRC.